BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VISTA ANTIGEN BRUCELLA MELITENSIS

    K Number: K972396 · Decision Aug 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    11
    Applicant Total
    10
    Review Days
    60

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    Basic Information

    Device Name
    VISTA ANTIGEN BRUCELLA MELITENSIS
    K Number
    K972396
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3085
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lee Laboratories, Inc.
    Date Received
    June 26, 1997
    Decision Date
    August 25, 1997
    Product Code
    GSO
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GSO Antigens (Febrile), Agglutination, Brucella Spp.

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    Other Clearances by Lee Laboratories, Inc.

    K Number Device Name
    K972392 VISTA ANTIGEN SALMONELLA H A
    K972391 VISTA ANTIGEN SALMONELLA H B
    K972386 VISTA ANTIGEN SALMONELLA O GROUP B
    K972395 VISTA ANTIGEN SALMONELLA O GROUP D
    K972390 VISTA ANTIGEN SALMONELLA H C
    K972389 VISTA ANTIGEN SALMONELLA H D
    K972388 VISTA ANTIGEN SALMONELLA O GROUP C
    K972387 VISTA ANTIGEN SALMONELLA O GROUP A
    K972394 VISTA ANTIGEN BRUCELLA ABORTUS